Clinical Study Administrator
- Experience Level
- Experienced (non-manager)
At PRA, we know that our people are our greatest strength, so we work hard to hire the very best.
If you join our team, you can expected to be challenged, rewarded and nurtured.
We have a dynamic and loyal workforce, a culture that values individuality and innovation and an ongoing commitment to employee growth and development. The result? A dynamic and loyal workforce who take pride in the their work on clinical development which changes lives.
As a Clinical Study Administrator (CSA) you will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognizes merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.
For this office-based position fully embedded to our client, the Clinical Study Administrator plays a key role in the success of global clinical trials at a local level. The tasks undertaken by a CSA are varied and can include:
- Assisting with the coordination and administration of clinical studies from the start-up to execution and close-out.
- Collecting, assisting in preparation, reviewing and tracking of documents for the application process (HA/IEC). Liaising with Investigators, external service providers, CRAs and Lead CRAs during the collection process to support effective delivery of a study and its documents.
- Operational responsibility to set-up the local Trial Master File (eTMF) and ISF including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) according to Good Clinical Practice (ICH/GCP).
- Contribute to the production and maintenance of study documents, ensuring template and version compliance. Translate or give the appropriate support with the translation of documents when required.
- Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities
- Set-up, populate and accurately maintain information in sponsor’s tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems
- Additional country-specific tasks depending on country need, as assigned.
As a Clinical Study Administrator you will have the opportunity to experience the full lifecycle of a project and genuinely contribute to drug development and improving patients’ lives.
You are: Detail-orientated, passionate and reliable.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
A relevant educational background, either in life-sciences or as a licensed healthcare professional
- Strong interpersonal skills
- Proficiency in MS Office
- The ability to manage multiple priorities simultaneously
- Very good written and spoken English and Danish
- A quality-focused mindset
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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